Cutaneous FistulaPhase 2/3NCT00294450
Feasibility Study of a New Fistula Pouching System
A Phase 2/3 study testing Fistula Pouching System in people with Cutaneous Fistula, run by Coloplast A/S at 7 sites in United States.
Trial summary
The purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Fistula
- What is being tested?
- Fistula Pouching System
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2006to Mar 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Capable of giving informed consent
- Have to be hospitalized
- Have a fistula with the opening on the skin in the abdominal area
Who cannot join
- Pregnant and/or breast-feeding
- Receiving radiation- or chemotherapy during the investigation period
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Morton Plant Hospital
Clearwarter, Florida, 33756
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Presbyterian Hospital of Dallas
Dallas, Texas, 75231
Fairview Southdale Hospital
Edina, Minnesota, 55435
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105
University of Minnesota Medical Center Fairview - Riverside
Minneapolis, Minnesota, 55454
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
About this study
Official title: Pouching of Fistula - a Non-comparative, Multi-center Investigation
The purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach.
- Conditions
- Cutaneous Fistula
- Being tested
- Fistula Pouching System
- Medical subject headings
- Cutaneous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fistula Pouching SystemDevice
Also called Fistula and Wound Management System
3 different sizes of fistula pounching system
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurse's preference to use the test product in the future
Measured: Up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thais Benjamin N. Christensen, M.Sc. (BME), Study chair, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294450
- Sponsor's protocol ID
- DK140OS
- Status last verified
- Jan 2012
- First submitted
- 20 Feb 2006
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pouching of Fistula - a Non-comparative, Multi-center Investigation
- ClinicalTrials.gov ID
- NCT00294450
- Acronym / sponsor ID
- DK140OS
- Conditions
- Cutaneous Fistula
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Capable of giving informed consent
- Have to be hospitalized
- Have a fistula with the opening on the skin in the abdominal area
Key exclusion criteria (2 listed)
- Pregnant and/or breast-feeding
- Receiving radiation- or chemotherapy during the investigation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fistula Pouching SystemAlso: Fistula and Wound Management System3 different sizes of fistula pounching system | Device | – |
Primary outcome
Nurse's preference to use the test product in the future
Time frame: Up to 18 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thais Benjamin N. Christensen, M.Sc. (BME) study chair
Coloplast A/S
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fistula Pouching System in people with Cutaneous Fistula, run by Coloplast A/S at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurse's preference to use the test product in the future (time frame: Up to 18 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2012; AzTrials last refreshed its copy on 6 Nov 2026.